In November of 2004, a pre-publication release of a Johns Hopkins School of Medicine study destined to appear in the Annals of Internal Medicine created a stir about the safety of vitamin E. The research, simultaneously released on the website of the Annals of Internal Medicine and reported at the American Heart Association's Scientific Sessions 2004, states that daily vitamin E doses of 400 international units (IU) or more can increase the risk of death and should be avoided. From this, headlines luridly touted the supposed finding that "Vitamin E Increases Death." What's the truth about the study, and how does it impact integrative physician's recommendations for this supplement?

First of all, the study is nothing new. A "meta-analysis" is simply a study of studies that have already been performed. It involves a set of statistically analyses based on manipulations of existing data. Even statisticians outside the vitamin community criticized the study as being too far-reaching in its conclusions that vitamin E might be unsafe. For example, the New York Times of November 11, 2004 wrote: "Their paper, however, failed to convince some statisticians, who noted that is notoriously difficult to pool data from disparate studies with different populations and weak results." Dr. David Freedman, as statistician at the University of California at Berkeley said in the Times: "As a statistician, I find this paper unpersuasive."

Moreover, the studies used to marshal evidence of the harmful effects of vitamin E all looked at sick populations already at high risk of death: patients with advanced heart disease, cancer, Alzheimer's, and kidney failure. Even the authors of the Johns Hopkins study themselves admit: "High dosage trials ( > 400 IU per day) were often small and were performed in patients with chronic diseases. The generalization of the findings to healthy adults is uncertain."

There is evidence of bias in the study in that the authors concentrated on perils of vitamin E when their own study revealed distinct protective effects, but at lower doses ( < 200 IU per day). Additionally, these studies mostly looked at the effects of synthetic vitamin E, when most complementary physicians are now advocating natural mixed tocopherols, which supply gamma tocopherol and tocotrienols. In practice, most nutritionally-oriented doctors are now prescribing vitamin E not as an isolated nutrient, as in most of the studies cited by Johns Hopkins, but as a component of a balanced program of antioxidant supplementation.

It is worth remembering that a recent study of approximately 90,000 nurses suggested that the incidence of heart disease was 30 to 40 percent lower among nurses with the highest intake of vitamin E from diet and supplements. Researchers found that the apparent benefit was mainly associated with intake of vitamin E from dietary supplements. High vitamin E intake from food was not associated with significant cardiac risk reduction.

Of interest is that a recent study by Johns Hopkins researchers published in the Annals of Neurology showed that 400 IUs of vitamin E in conjunction with 500 mg of vitamin C reduced the risk of Alzheimer's by 60 percent.

ACAM recognizes that hundreds of studies attest to the safety and benefits of high-dose vitamin E. Our concern is that this new highly-publicized analysis will "poison the well" for the millions of Americans who seek to benefit from the protective effects of this nutrient. Additionally, we anticipate that this skewed data will be used to form the cutting edge of a new initiative by government regulators and conservative members of the medical establishment to further regulate the supplement industry. Already, several proposals are being advanced, here and in Europe, to place significant caps on available doses of nutritional supplements in a misguided effort to "protect" the public.

BOTTOM LINE: While numerous drugs continue to be aggressively marketed with unacceptable safety profiles, resulting in thousands of otherwise avoidable deaths and injuries each year, a safe and effective vitamin is being subject to unfair attack based on a single poorly-designed study which has arrived at erroneous conclusions. Clearly, before any action is taken to discourage the use of vitamin E, further studies are needed to prove any lack of safety.

The American College for Advancement in Medicine (ACAM) is a not-for-profit medical society dedicated to educating physicians and other health care professionals on the latest scientific research and emerging breakthroughs in integrative medicine. Celebrating more than a quarter century of service, ACAM represents more than 1,000 physicians in 30 countries. ACAM is the largest and oldest organization of its kind in the world dedicated exclusively to advancing the field of medicine by educating physicians about groundbreaking research and scientific discoveries in integrative medicine.